Welcome to our dedicated page for BIONTECH news (Ticker: BNTX), a resource for investors and traders seeking the latest updates and insights on BIONTECH stock.
BioNTech SE (NASDAQ: BNTX) generates frequent news flow as a global next generation immunotherapy company focused on oncology, mRNA technologies and COVID-19 vaccines. Its updates often cover progress across a diversified oncology pipeline that includes mRNA cancer immunotherapies, next-generation immunomodulators, antibody-drug conjugates (ADCs) and chimeric antigen receptor (CAR) T cell therapies, as well as developments in its mRNA vaccine programs for infectious diseases.
Investors following BioNTech news can expect regular announcements on clinical trial milestones in major tumor types such as lung, breast, gynecologic, gastrointestinal and genitourinary cancers. Recent releases have highlighted late-stage data readouts and trial initiations for investigational agents like pumitamig (a PD-L1xVEGF-A bispecific antibody co-developed with Bristol Myers Squibb) and gotistobart (a CTLA-4–targeting Treg modulator), including Phase 2 and Phase 3 results in indications such as triple-negative breast cancer and squamous non-small cell lung cancer.
BioNTech’s news stream also includes corporate and financial updates, such as quarterly results, guidance changes, and details of its cash and investment position. The company reports on its COVID-19 vaccine franchise, including launches of variant-adapted vaccines for specific vaccination seasons, and comments on how vaccine market dynamics affect revenues.
Another recurring theme in BNTX news is strategic transactions and partnerships. BioNTech has announced an all-stock acquisition of CureVac N.V. to strengthen its position in mRNA design, delivery formulations and manufacturing, and regularly issues releases on its collaboration with partners including Bristol Myers Squibb, Duality Biologics, OncoC4, Pfizer and others.
This news page aggregates these developments in one place, allowing readers to track BioNTech’s clinical progress, partnership activity, financial disclosures and strategic updates over time.
BioNTech (NASDAQ: BNTX) has announced its second AI Day event, part of the company's Innovation Series, scheduled for October 1, 2025, at 9:00 AM EDT in London. The event will showcase BioNTech's artificial intelligence strategy and capabilities, particularly focusing on AI applications in their pipeline and internal processes.
The presentation will be accessible through a live webcast, with slides and recording available on BioNTech's Investor Relations website for one year following the event. This event marks a significant milestone in BioNTech's continued focus on AI development, following their acquisition of InstaDeep Ltd.
BioNTech (NASDAQ: BNTX) and Bristol Myers Squibb have revealed promising interim Phase 2 data for their PD-L1xVEGF-A bispecific antibody pumitamig in treating extensive-stage small cell lung cancer (ES-SCLC). The trial demonstrated remarkable efficacy with a 76.3% confirmed objective response rate and a 100% disease control rate.
Key results include median progression-free survival of 6.8 months and an impressive 56.7% mean tumor shrinkage, with 89.5% of patients achieving early tumor reduction. The treatment showed a manageable safety profile with only a 14% discontinuation rate. These results support the ongoing global Phase 3 ROSETTA LUNG-01 trial and pumitamig's potential as a new standard of care for ES-SCLC patients.
Pfizer (NYSE:PFE) and BioNTech have announced positive topline results from their Phase 3 clinical trial of the LP.8.1-adapted COVID-19 vaccine 2025-2026 Formula. The study involved 100 participants, including adults aged 65+ and those 18-64 with risk conditions for severe COVID-19.
The trial demonstrated that 14 days post-vaccination, participants showed at least a 4-fold increase in LP.8.1-neutralizing antibody titers compared to pre-vaccination levels. The safety profile remained consistent with previous studies, with no new safety concerns identified.
These findings support the recent FDA approval of the LP.8.1-adapted COVID-19 vaccine and reinforce its potential effectiveness against multiple circulating SARS-CoV-2 sublineages.
BioNTech (NASDAQ:BNTX) and Pfizer have received FDA approval for their LP.8.1-adapted monovalent COVID-19 vaccine COMIRNATY® for adults 65 and older, and individuals 5-64 years with high-risk conditions. The 2025-2026 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, selected based on FDA guidance to better match circulating strains.
Pre-clinical data shows the vaccine generates improved immune responses against multiple SARS-CoV-2 sublineages, including XFG and NB.1.8.1, compared to previous JN.1 and KP.2-adapted versions. Immediate shipping will begin to ensure widespread availability across U.S. pharmacies, hospitals, and clinics.
To date, 5 billion doses of the Pfizer-BioNTech COVID-19 vaccine have been distributed globally, maintaining a favorable safety and efficacy profile supported by extensive real-world evidence.
BioNTech (NASDAQ:BNTX) reported Q2 2025 financial results and significant strategic developments. The company recorded revenues of €260.8 million and a net loss of €386.6 million (€1.60 per share). Key highlights include a major collaboration with Bristol Myers Squibb for BNT327 development, featuring a $1.5 billion upfront payment and potential milestone payments up to $7.6 billion.
The company maintains a strong financial position with €16.0 billion in cash and investments. BioNTech reaffirmed its 2025 revenue guidance of €1.7-2.2 billion. The company received approval for a new variant-adapted COVID-19 vaccine in Europe, with deliveries expected to begin in August 2025.
Strategic developments include the announced acquisition of CureVac and advancement of oncology programs, particularly in pan-tumor treatments. R&D expenses were €509.1 million for Q2 2025, showing the company's continued investment in pipeline development.
BioNTech (NASDAQ:BNTX) and Pfizer have received a positive CHMP opinion for their LP.8.1-adapted COVID-19 vaccine in the European Union. The updated vaccine demonstrates improved immune response against dominant variants including XFG and NB.1.8.1 compared to 2024-2025 formulations.
Upon European Commission authorization, the vaccine will be available for individuals 6 months and older. The companies have already initiated manufacturing to ensure supply readiness for the upcoming fall/winter season, with doses ready to ship immediately following EC approval.
The recommendation is supported by comprehensive clinical, non-clinical, and real-world data, with over a billion doses administered globally demonstrating favorable safety and efficacy profiles.
BioNTech (NASDAQ: BNTX) has scheduled its second quarter 2025 financial results announcement and corporate update for August 4, 2025. The company will host a conference call and webcast at 8:00 a.m. EDT (2:00 p.m. CEST) on the same day.
Investors and analysts can access the conference call via telephone by registering through a provided link, which will supply dial-in numbers and a PIN. The presentation slides and webcast will be accessible through the company's website, with a replay available for 30 days after the event.
BioNTech (NASDAQ: BNTX) announced that Chief Strategy Officer Ryan Richardson will step down from the Management Board effective September 30, 2025. Richardson, who joined in 2018 and served as CSO since January 2020, played a crucial role in the company's development, including raising over $1 billion in capital through Series B financing, IPO, and follow-on offerings.
During his tenure, Richardson led Global Strategy and Corporate Development functions, overseeing more than a dozen collaborations and acquisitions. He also managed Capital Markets and Investor Relations, expanding analyst coverage and strengthening BioNTech's global shareholder base. His responsibilities will be transitioned to other Management Board members to ensure a smooth handover.
BioNTech SE (Nasdaq: BNTX) reported Q1 2025 financial results with revenues of €182.8 million, primarily driven by COVID-19 vaccine collaboration. The company posted a net loss of €415.8 million and loss per share of €1.73. Despite losses, BioNTech maintains a strong financial position with €15.9 billion in cash and investments.
Key highlights include advancement in oncology pipeline, particularly BNT327 (PD-L1xVEGF-A bispecific antibody) and mRNA cancer immunotherapies. The company confirmed its 2025 revenue guidance of €1.7-2.2 billion and announced preparation for 2025/2026 variant-adapted COVID-19 vaccine.
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